Genetic Hypertension, Hypertension Essential, Salt Excess
Conditions
Keywords
Hypertension, Salt
Brief summary
The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.
Detailed description
The study is carried out to evaluate primarily the difference in the activity of the renal transporter ENaC (through dosage of sodium) through its inhibition with a single dose of Amiloride in hypertensive patients characterized by the polymorphism of alpha Adducin rs496. It's also aimed to see the difference in potassium and the change in systolic and diastolic blood pressure after amiloride administration
Interventions
DRUGAmiloride
administration of a single dose of 5 or 10 mg of Amiloride (based on body weight) After oral intake of the drug, the increase in sodium in the urine ends within 8 hours
Sponsors
Ospedale San Raffaele
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* male patients aged 18-60 years; * naïve hypertensive patients: newly diagnosed, never previously treated for hypertension; * BMI\<30 Kg/m2, * documented first degree essential arterial hypertension (mean of the last 3 consecutive systolic BP measurements must be \>=140 mmHg or diastolic BP \>=90 mmHg; * signature of the informed consent for participation in the study * patient who has already undergone genomic DNA sampling (accompanied by relative consent) and genotyped for the ADD1 rs4961 variant (GG, GT or TT).
Exclusion criteria
known causes of secondary hypertension; * severe or malignant hypertension; history of renal artery disease; * significant renal disease (creatinine clearance less than 60 ml/min); * hyperkalemia (Kpl \> 6mEq/l) at enrollment visit; * hypercalcaemia (Ca pl \> 2.6 mmol/l) at enrollment visit; * symptomatic hyperuricemia (\> 7.5 mg/dl); * liver disease (transaminases greater than 3 times the normal value); * cardiac pathologies (myocardial infarction, atrial fibrillation, etc.); * diabetes (fasting blood sugar \>125mg/dl); * in therapy with statins, NSAIDs, systemic steroids; * known hypersensitivity to Amiloride or to any of the excipients; * patients unable to express a valid consent -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate urinary sodium | 3 hrs and 6 hrs | Evaluation of sodium levels after oral administration of Amiloride |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate potassium levels | 3 hrs and 6 hrs | Evaluation of potassium plasma levels after oral administration of Amiloride |
| Evaluation of systolic blood pressure | 3 hrs and 6 hrs | Evaluation of systolic blood pressure after oral administration of Amiloride |
| Evaluation of diastolic blood pressure | 3 hrs and 6 hrs | Evaluation of diastolic blood pressure after oral administration of Amiloride |
Countries
Italy
Outcome results
None listed